USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the “newly characterized antigen test” for written description of antibodies, and advises that additional written description examination guidance is forthcoming.

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Are These INOMax Therapeutic Method Claims Directed To A Natural Phenomenon?

In Mallinckrodt Hospital Prods. IP Ltd. v. Praxair Distrib., Inc., Judge Sleet of the U.S. District Court for the District of Delaware invalidated personalized method of treatment claims under 35 USC § 101 as being directed to a natural phenomenon. If the Federal Circuit affirms the decision, will it leave room to draw a line that spares other methods of treatment?

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When Does An RCE Stop The PTA Clock?

In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination (RCE) stops that PTA clock, but in Ariad Pharmaceuticals, Inc. v.  Matal, the U.S. District Court for the Eastern District of Virginia found that the clock should keep running when the USPTO mishandles an RCE. So, exactly when does an RCE stop the PTA clock?

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PTAB Enters Sua Sponte Patent Eligibility Rejections

We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance. Apparently, applicants should be wary about appealing any rejection of a diagnostic method claim, because the PTAB may enter sua sponte patent eligibility rejections even if the examiner did not make a § 101 rejection. Continue reading this entry

Federal Circuit Emphasizes Need For Reasonable Expectation Of Success

In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the asserted prior art references failed to provide a reasonable expectation of success. While a non-precedential decision, this case illustrates the important role that unpredictability in the art and a lack of expectation of success can play in biotechnology patents.

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